Quality Control Analyst II

10 - 15 years

12 - 17 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

 
How you ll spend your day

  • Detailed description of MAIN tasks and responsibilities:
  • Performing Stability analysis, Method transfer, Method Validation and review of analytical documents.
  • Preparation and review of Method Transfer Protocols (MTP), Method transfer report (MTR), Method of analysis (MTH), Standard Testing Procedure, Test Data Sheet (TDS) for Stability Analysis, Method transfer and Method Validation, Stability Summary Reports and any document related to stability analysis, method transfer and method validation in compliance with current guidelines. Review and maintenance of all logbooks of the department
  • Preparation of departmental SOP s in compliance with current guidelines. Review of departmental SOP s, training of analysts and other technical staff and review validation of data transfer, data management using computer systems.
  • Preparation and review of validation protocols in compliance with current guidelines.
  • Calibration and validation of all instruments / equipments.
  • Entry of stability sample results in LIMS & SAP.
  • Handling of LSCMS software
  • Initiation of Quality Forms in Track wise Harmony, documents in Glorya EDMS and CAPA in Trackwise Harmony.

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